Medtronic, Inc. recalls OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead…
Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.
Read the official notice →- Date
- 2026-11-04
- Country
- United States
- Brand
- Medtronic
- Product
- OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead…
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of AZ, CA, CT, DE, FL, GA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medtronic recalls
- 2026-11-04
Medtronic, Inc. recalls CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable
Software problem has the potential for an inaccurate displayed longevity estimate.
- 2026-05-06
Medtronic, Inc. recalls Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac…
- 2026-01-21
Medtronic Inc recalls Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090…
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
FDA · DeviceMedtronic IncWorldwide - US Nationwide and the countries of Argentina, Australia, Austria,…Official notice →- 2025-12-10
Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
- 2025-07-30
Medtronic, Inc. recalls Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application,…
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's…
- 2025-07-23
Medtronic, Inc. recalls Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure…
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a…
USOther drugs & medical recalls in the United States
- 2026-11-04
Canon Medical System, USA, INC. recalls ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.
FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL,…Official notice →Philips North America recalls Model Number: 712010.
Potential for the device to fail immediately after an exposure, causing the system to remain stationary.
FDA · DevicePhilips North AmericaWorldwide Distribution: (US Nationwide) and International distribution to…Official notice →ZIEHM-ORTHOSCAN INC recalls Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart.
FDA · DeviceZIEHM-ORTHOSCAN INCWorldwide - US Nationwide distribution in the states of AZ , CA , CO , CT , FL…Official notice →Ethicon, LLC recalls ETHILON Nylon Suture, Product Code 697G
Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury,…
Abiomed, Inc. recalls Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge…
FDA · DeviceAbiomed, Inc.Worldwide Distribution: US (nationwide) and OUS (foreign) to countries:…Official notice →MSN Laboratories Private Limited (Formulations Division,… recalls Atorvastatin Calcium Tablets, USP, 40mg, 1000 tablets per bottle, Rx only, Manufactured by: MSL…
Presence of Foreign Tablets/Capsules
FDA · DrugMSN Laboratories Private Limited (Formulations Division,…Nationwide in the USA.Official notice →